Hemofilter Life Span, ECLS And/or CRRT

NCT ID: NCT04193865

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-09

Study Completion Date

2024-03-25

Brief Summary

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The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

Detailed Description

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Via collection of serum and ultrafiltrate samples, the invesitgators will examine how hemofilter lifespan alters the filtration of pro- and anti-inflammatory cytokines.

Conditions

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Kidney Diseases Acute Injury of Kidney Renal Failure Renal Insufficiency Neonatal Renal Disorder (Disorder)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Extracorporeal Life Support with Renal Replacement Therapy

This cohort will include all subjects receiving extracorporeal life support with concurrent continuous renal replacement therapy.

Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each participants's CRRT course.

No interventions assigned to this group

Renal Replacement Therapy

This cohort will include all subjects receiving continuous renal replacement therapy (no extracorporeal life support).

Two blood samples and one ultrafiltration sample will be obtained for the study protocol twice per day (every 12 hours) for the duration of each patient's CRRT course.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Neonatal or pediatric patients receiving ECLS (\>2 kilograms and \>34 weeks gestation)
* CRRT utilized during ECLS course
* For the secondary endpoints comparing CRRT-mediated cytokine filtration in patients receiving ECLS with concurrent CRRT to patients receiving CRRT alone (no ECLS), the investigators will also enroll neonatal and pediatric patients receiving CRRT alone (no ECLS). Patients will be eligible for entry into this study if they meet all of the following criteria:
* Neonatal or pediatric patients receiving CRRT

Exclusion Criteria

-Those patients with inability or unwillingness of legal guardian/representative to give informed consent
Minimum Eligible Age

0 Days

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical Univeristy of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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00094177

Identifier Type: -

Identifier Source: org_study_id

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